MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT; SURGICAL MESH

Catalog Number	0117070
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	11/05/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2013 - patient was diagnosed with right direct and indirect inguinal hernia thereby underwent open repair with implant of perfix light plug (device 1 and 2).Per op notes, "an incision was made in the area over the right inguinal ligament.The hernia sac was identified and the sac was dissected free of the cord and reduced back into the abdominal cavity.A direct inguinal hernia was identified.A large and medium perfix light plug (device 1 and 2) were placed into the internal inguinal ring and secured in place with sutures." (b)(6) 2015 - patient was diagnosed with right inguinal hernia thereby underwent robotic assisted laparoscopic repair with implant of synthetic mesh.Per op notes, "an incision was made below the umbilicus.A large defect was noted in the right inguinal region.Omentum was noted to be herniated through the defect and it was dissected free from the hernia sac which was chronically scarred in.The hernia sac was reduced and completely freed up.A synthetic mesh was placed and secured with suture.".
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jun-2012) is considered to be a best estimate.This emdr represents the bard perfix light plug (device 2).An additional supplemental emdr was submitted to represent the bard perfix light plug (device 1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PERFIX PLUG LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 25363524
• Report Number: 1213643-2026-00702
• Device Sequence Number: 10679687
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963(17)170728(10)HUWF2503
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2017
• Device Catalogue Number: 0117070
• Device Lot Number: HUWF2503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 107 KG